Endoscopic surgery has helpedmanya patient—usually without the need for a long recovery period—thanks to the small incisions involved. Often this type of surgery relies on tools such as the new Triclip, which looks like a three-finger grabber. This tool finds use only in the gastrointestinal tract, though, where it helps surgeons treat bleeding blood vessels, polyps, ulcers, or other problems.
In an operating room, a surgeon uses an endoscope, basically a fiber-optic camera, to locate a surgical site. The camera's flexible fiber-optic bundle includes a small channel, so the surgeon can insert a Triclip cable and move it directly to the site of the medical problem. Then, by manipulating the Triclip's cable, the surgeon can place the clip and snap it in place to cut off blood flow or to clamp tissue as needed.
Previous clip designs provided two prongs, but the Triclip's three-fingered design gives a surgeon more flexibility in positioning and attaching a clip, and it provides pressure from three directions.
"One other clip was available, but no one had made any improvements in over 10 years," says Vihar Surti, developer of the Triclip. But he notes, "The development of an easy-to-use handle presented the biggest design challenge." Surti joined Wilson-Cook Medical (http://rbi.ims.ca/3846-561) three years ago, right after graduation from North Carolina State University.
Because Wilson-Cook manufactures many medical devices that use small plastic handles, Surti thought at first he might adapt one for use with the Triclip. "Those first prototypes went through a complete series of tests, but they didn't properly position the clip, and they cost too much," Surti says.
Surti used 3D modeling software to produce a virtual handle he could examine and "test" to the extent made possible by his CAD tools. His goal: One-hand operation that made it easy to place a Triclip properly, snap it into position, and then release it from its cable.
After checking the 3D virtual design, Surti moved on to a real device. "A rapid-prototyping system used my CAD files to build a stereolithography model, layer by layer," says Surti. "That model device didn't get used, it simply let me see how things operated and fit together." After proving the handle design would work, Surti got approval to buy a mold for the Triclip handle.
When it came time to test a complete Triclip, Surti couldn't just ask for volunteers. Instead, he used the units on dried pig tissue, and after proving the device would work as expected, testing moved on to live pigs and dogs. Those tests checked the function, strength, and other characteristics of the clips. Finally Wilson-Cook obtained 510(k) approval from the U.S. Food and Drug Administration to use the device on human patients.
Those who undergo surgery that involves a Triclip need not worry about setting off alarms at metal detectors. According to Surti, "After a lesion heals, the clip detaches and it passes out without a patient even knowing it." When clamped shut, a Triclip looks like a small, smooth bit of metal.
Gotcha: A Triclup assists in
gastrointestinal surgery by stemming blood flow under remote control.
After a surgeon attaches it, the three-prong clip drops off the probe,
holds fast until tissue heals, and then passes through the intestinal
Surti feels he found the right career. Although his family wanted him to become a physician, he followed in the footsteps of older brothers, one an engineer and another a computer scientist, and chose a technical career. "I knew I wanted to study biomedical engineering right from the start at NC State," says the inventor.
Vihar Surti graduated in 2000 from North Carolina State University, with a Bachelor's degree in Biomedical Engineering. Since graduating, he has worked for Wilson-Cook Medical as a biomedical research engineer. He has four patents pending, and in his spare time, he enjoys reading science fiction and rooting for the Carolina Panthers.